FDA OKs Potent Hepatitis C Drug
By LAURAN NEERGAARD AP Medical Writer
WASHINGTON (AP) -- Thousands of patients who relapsed using the only medicine for liver-destroying hepatitis C won new hope Wednesday with approval of a therapy that promises to be almost 10 times more effective than standard treatment.
Rebetron, a combination treatment that won Food and Drug Administration approval for relapsed hepatitis C patients, is not a cure -- and it poses some serious risks, including severe birth defects, anemia and even some suicides.
But in studies of patients who relapsed after standard treatment, 45 percent who took Rebetron had undetectable virus levels, compared with just 5 percent of patients who merely tried standard therapy again.
''This is an important step forward,'' said liver specialist Dr. Willis Maddrey of the University of Texas Southwestern Medical Center, who advises several hepatitis drug manufacturers. Using a multidrug approach is ''attacking the virus on several fronts. ... A large number of people ... should have hope now.''
But not all relapsed hepatitis patients will be good candidates for Rebetron because it's tough to take and causes numerous side effects, some quite dangerous, stressed the FDA.
''This is the sort of therapy best used in the hands of really well-trained specialists,'' said Dr. Heidi Jolson, FDA's antiviral chief. ''There are real risks with this therapy.''
The majority of patients suffer flulike symptoms for the first few weeks. But the FDA had greater concerns, warning that:
--All Rebetron users must use birth control during the therapy and for six months afterward until the potent medicine fully clears their bodies. Rebetron can cause serious birth defects and even fetal death; it also can affect sperm, so male hepatitis sufferers and their partners also must use birth control.
Manufacturer Schering-Plough Corp. is preparing patient advisories that urge a pregnancy test before women begin taking the drug, and some doctors say they'll test during treatment, too.
--Some people with cardiovascular disease or a history of blood disorders should not use Rebetron because it can cause anemia. All patients require blood monitoring, particularly during the first four weeks of therapy, to catch those whose blood counts drop dangerously.
--Depression may occur in about 20 percent of patients, as may insomnia and irritability. The FDA said it knows of rare cases of suicides or suicide attempts and stressed that patients who feel depressed should immediately tell a doctor -- and doctors must take depression symptoms seriously.
Rebetron is a combination of interferon A injections, today's standard treatment, and a new oral version of the antiviral drug ribavirin. It's a complicated treatment that lasts six months: taking up to six capsules every day of ribavirin, plus interferon injections three times a week.
Schering-Plough said it would begin shipping Rebetron to pharmacies Monday. Cost estimates range from $6,400 to $8,600 for the six months of treatment, depending on the patient's weight. That's in the same range as standard interferon treatment, Schering said.
About 4 million Americans have hepatitis C, which kills about 10,000 annually and is the leading reason for liver transplants.
The vast majority of patients caught the virus from contaminated intravenous drug needles. But thousands were infected by blood transfusions prior to 1992, when scientists developed the first effective way to protect the blood supply.
Many don't know they're infected because they experience few if any symptoms for years, and about 15 percent of patients recover on their own.
But others develop serious, even fatal, liver disease. Only about 40 percent respond to standard treatment with interferon, a synthetic version of an immune system protein that naturally fights viruses -- and of those, half will later relapse.
It is those patients for whom Rebetron is targeted. Schering found the combination therapy significantly more potent than merely trying interferon again: Six months after treatment ended, 34 percent of patients treated with interferon alone had some improvement in liver inflammation, but 50 percent of the Rebetron patients' livers had improved.
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AP-NY-06-03-98 1704EDT
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